Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation

NCT04502758 | Recruiting DMC FDA Device

• 2 other identifiers: 20-009630-1R01MH124655-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to gather information regarding the use of a new type of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) for suicidal ideation in adolescents with Major Depressive Disorder (MDD). The investigators hope to learn if this TMS treatment improves suicidal ideation over 10 days and clinical outcomes over 1 year of follow-up.

Conditions

Suicidal Ideation; Major Depressive Disorder

Keywords

Adolescent

Outcome Measures

Primary Outcomes (2)

• Suicidal Ideation

  Suicidal Ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS). This is a validated, clinician-rated tool collected to assess lifetime and ongoing suicidal ideation and behavior. The severity of ideation subscale is a 5-point ordinal scale 1-5 . 1 = Wish to be dead - 5 = Active Suicidal Ideation with Specific Plan and Intent. Assessed at baseline, 10 days and 12 months.

  up to 12 months

• Hospitalizations

  The total number of hospitalizations related to suicide idealization

  up to 12 months

Secondary Outcomes (1)

• Cortical inhibition

  baseline, 10 days

Study Arms (2)

Sequential bilateral accelerated theta burst stimulation

ACTIVE COMPARATOR

Three sessions of Sequential bilateral accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).

Device: MagVenture TMS Therapy System w/Theta Burst Stimulation

Sham seqential billateral accelerated theta burst stimulation

SHAM COMPARATOR

Three sessions of Sequential bilateral sham accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).

Device: Sham MagVenture TMS Therapy System w/Theta Burst Stimulation

Interventions

MagVenture TMS Therapy System w/Theta Burst Stimulation DEVICE

During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The device consists of a magnetic stimulator, MagPro X100 and a magnetic coil used for MT determination, C-B70 and a treatment coil, the Cool-B70 A/P coil. The A/P version of the coil, contains both an active site (A) and a sham (P) site. The magnetic field properties on the active site are identical to that of the standard Cool-B70 coil, cleared for iTBS treatment.

Also known as: The MagVenture TMS Therapy System w/Theta Burst Stimulation

Sequential bilateral accelerated theta burst stimulation

Sham MagVenture TMS Therapy System w/Theta Burst Stimulation DEVICE

During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The device consists of a magnetic stimulator, MagPro X100 and a magnetic coil used for MT determination, C-B70 and a treatment coil, the Cool-B70 A/P coil. The A/P version of the coil, contains both an active site (A) and a sham (P) site. The magnetic field on the sham site is significantly reduced, and is less than 5% of that of the active site.

Sham seqential billateral accelerated theta burst stimulation

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Inpatients or outpatients
• Voluntary clinical patient with the capacity to assent to treatment and a parent or legal guardian with the capacity to consent
• Female or male
• years of age
• Diagnosed with MDD based on Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) criteria122 with the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid) in subjects 12-17 years of age;118 The Mini-International Neuropsychiatric Interview will be used for subjects who are 18 years of age117
• In a current episode of MDD with duration of at least 4 weeks but less than 3 years
• Depressive symptom severity as demonstrated by CDRS-R total composite score of 40 or greater and a suicidal ideation score of 3 or more on item 13 of the CDRS-R109
• Demonstrating that depressive symptom severity as evaluated at the screening visit does not improve between screening and baseline by 25% or more
• Eligible for transcranial magnetic stimulation (TMS) based on safety criteria104
• On a medically acceptable form of birth control if female
• Taking an antidepressant medication if recommended by the referring clinician and agreed upon by parents and patients. Please note that patients are not required to take an antidepressant medication for study participation for practical, ethical, and human subject protection concerns. Medication status and prior treatment resistance will be carefully recorded with the Antidepressant Treatment History Form113 criteria for relevant statistical considerations.

You may not qualify if:

• Diagnosis of a psychotic disorder, bipolar disorder, anorexia nervosa, bulimia nervosa, substance use disorders within the past year (with the exception of caffeine and tobacco).
• Intelligent quotient less than 70 (if there is a clinical concern, subjects will be psychometrically assessed with the Slosson Intelligence Test, Revised).123
• Positive urine drug screen at baseline
• Seizure history
• Any family history of epilepsy
• History of any treatment with electroconvulsive therapy or TMS
• Use of any investigational drug within 4 weeks of baseline
• Prior brain surgery
• Risk for increased intracranial pressure such as a brain tumor
• Head trauma with loss of consciousness
• Any true positive findings on the TMS safety screening form
• Pregnancy or suspected pregnancy
• Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head-within 30 cm of the treatment coil excluding the mouth that cannot be safely removed (examples include cochlear implants, vagus nerve stimulators, deep brain stimulators, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes).
• Implanted medication pumps and cardiac pacemakers
• Any unstable medical condition

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (6)

• Sonmez AI, Camsari DD, Nandakumar AL, Voort JLV, Kung S, Lewis CP, Croarkin PE. Accelerated TMS for Depression: A systematic review and meta-analysis. Psychiatry Res. 2019 Mar;273:770-781. doi: 10.1016/j.psychres.2018.12.041. Epub 2018 Dec 7.

  PMID: 31207865 BACKGROUND

• Lewis CP, Camsari DD, Sonmez AI, Nandakumar AL, Gresbrink MA, Daskalakis ZJ, Croarkin PE. Preliminary evidence of an association between increased cortical inhibition and reduced suicidal ideation in adolescents treated for major depression. J Affect Disord. 2019 Feb 1;244:21-24. doi: 10.1016/j.jad.2018.09.079. Epub 2018 Sep 28.

  PMID: 30292987 BACKGROUND

• Croarkin PE, Nakonezny PA, Deng ZD, Romanowicz M, Voort JLV, Camsari DD, Schak KM, Port JD, Lewis CP. High-frequency repetitive TMS for suicidal ideation in adolescents with depression. J Affect Disord. 2018 Oct 15;239:282-290. doi: 10.1016/j.jad.2018.06.048. Epub 2018 Jul 18.

  PMID: 30031247 BACKGROUND

• Lewis CP, Nakonezny PA, Blacker CJ, Vande Voort JL, Port JD, Worrell GA, Jo HJ, Daskalakis ZJ, Croarkin PE. Cortical inhibitory markers of lifetime suicidal behavior in depressed adolescents. Neuropsychopharmacology. 2018 Aug;43(9):1822-1831. doi: 10.1038/s41386-018-0040-x. Epub 2018 Mar 14.

  PMID: 29703993 BACKGROUND

• Dhami P, Knyahnytska Y, Atluri S, Lee J, Courtney DB, Croarkin PE, Blumberger DM, Daskalakis ZJ, Farzan F. Feasibility and clinical effects of theta burst stimulation in youth with major depressive disorders: An open-label trial. J Affect Disord. 2019 Nov 1;258:66-73. doi: 10.1016/j.jad.2019.07.084. Epub 2019 Jul 30.

  PMID: 31398593 BACKGROUND

• Yuruk D, Ozger C, Garzon JF, Leffler JM, Shekunov J, Vande Voort JL, Zaccariello MJ, Nakonezny PA, Croarkin PE. Sequential bilateral accelerated theta burst stimulation in adolescents with suicidal ideation associated with major depressive disorder: Protocol for a randomized controlled trial. PLoS One. 2023 Apr 13;18(4):e0280010. doi: 10.1371/journal.pone.0280010. eCollection 2023.

  PMID: 37053246 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Suicidal Ideation; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Paul Croarkin, DO, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlie Hoth

CONTACT

(507) 422-2605; hoth.charlie@mayo.edu

Courtney Caves

CONTACT

wolf.courtney@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The use of the MagVenture Cool-B70 A/P coils facilitates blinding of the operator and subjects receiving aTBS or sham treatments. The study team members completing clinical rating scales will also not be allowed in the treatment suite during TBS treatment sessions and will be blinded to treatment assignment. A pre-post treatment expectancy and experience form will ask subjects and parents to make a guess regarding treatment arm (active or sham). Blinded study team members will also be asked to guess treatment assignments for each subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: April 4, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)